HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments and tendons of the shoulder is an effective treatment that decreases pain, increases functional capacity and promotes healing better and in less time than standard treatment with physiotherapy.

OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited and assigned randomly into one of three groups of 25 to receive one of these three different treatments:

Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will receive physiotherapy every other week for three months. To avoid placebo effects, patients, the radiologist and physiotherapist will not know to which treatment group the patients belong; the physician administering the injections will not be involved in assessing disability before or after treatment. (Note: The physician will know which patients belong to group C because it will be obvious: they are delivering a subcutaneous - versus a joint - injection).

There will be three sets of injections - one set per month for 3 months. The patients' condition will be tracked for nine months after the first treatment, to monitor changes in 3 outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as assessed by ultrasound).

Disabilities of the arm shoulder and hand questionnaire [ Time Frame: Immediately after first injection, 1,2,3, six months ] [ Designated as safety issue: No ]

http://www.dash.iwh.on.ca/assets/images/pdfs/DASH_quest06.pdf 30 questions assessing ability to use shoulder in everyday activities, each question scored 1 to 5, where one is normal, no problem and five is unable to perform.

Phone call asking: how much pain they had (none, mild, moderate, severe), whether shoulder pain was affecting their ability to perform the activities of daily living (ADLs) (yes or no), how would they rate the shoulder pain now (none, mild, moderate, severe), how satisfied were they with their treatment (extremely satisfied, satisfied, neutral, dissatisfied, extremely dissatisfied ), whether they used other therapies for shoulder pain since completion of treatment (yes or no), which ones?, how much time did they spend off work because of their shoulder pain?

total prescription pain medication used [ Time Frame: 20 minutes before first injection on first day of patient visit, six months ] [ Designated as safety issue: No ]

25% dextrose and .1% lidocaine injected in the rotator cuff ligaments and tendons.

Procedure: shoulder injections

injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.

Other Names:

Prolotherapy

regenerative injection therapy

Active Comparator: .1% lidocaine in ligaments and tendons

.1% lidocaine injected in the shoulder ligaments and tendons

Procedure: shoulder injections

injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.

Other Names:

Prolotherapy

regenerative injection therapy

Placebo Comparator: .1% lidocaine subcutaneous

.1% lidocaine injected subcutaneously above the ligaments and tendons of the shoulder.

Procedure: shoulder injections

injections of 1 mL of solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.

conditions requiring anti-inflammatory medications including prednisone, corticosteroid injection less than eight weeks prior to the first set of injections

use of immune suppressants

symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint

age over 75 or under 19

adhesive capsulitis based on a thorough physical examination, where shoulder flexion or abduction is below 100 °, horizontal adduction is below 30 °, the hand behind the back is below the waist, external rotation is less than 30 °

full thickness tear greater than 1.2 cm as seen on ultrasound

autoimmune disorders such as lupus or rheumatoid arthritis

neurological disorders including Parkinson, seizures, and dementias are excluded for patient safety during the procedures

HIV, viral hepatitis and other blood borne communicable diseases, to protect the investigators

calcium deposits greater than 8 mm in diameter

type III acromion as seen on x-ray

painful condition elsewhere in the body likely to cloud the subject's assessment of his shoulder pain

no evidence of tendinopathy as seen on ultrasound

uncontrolled diabetes: A1C > 7

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01402011